A completed training record proves training occurred. It does not always prove someone can perform the work correctly. Learn how to distinguish training, understanding, and demonstrated competency.
A training record can prove that someone attended training, that an SOP was assigned, and when the training occurred. What it does not automatically prove is that the employee can perform the work correctly.
In many quality systems, the training process effectively ends when a record changes from Assigned to Complete. But for activities that can meaningfully affect product quality, data integrity, patient safety, customer requirements, or regulatory compliance, the more important question may be: can this person actually perform the assigned task correctly?
Training and competency are related. They are not the same thing.
Training tells you what was provided. Competency tells you whether the person can apply it.
Consider an employee who is assigned a revised procedure. They open the SOP, read it, click “Complete,” and generate a training record. The system can now demonstrate that training occurred.
But do we know whether the employee:
Not necessarily. That is why the level of training verification should reflect the risk and complexity of the work.
In a July 21, 2026 warning letter to Koven Technologies, FDA reviewed the firm’s response to quality-system deficiencies. The company provided records showing employees had been trained on updated procedures.
FDA acknowledged the records but asked for more. The agency stated that the firm had not provided sufficient specifics regarding the evaluation conducted to confirm they understood the updates.
The distinction is important: training records existed. The remaining question was whether understanding had actually been evaluated.
Source: U.S. Food and Drug Administration. Koven Technologies, Inc. — Warning Letter 734643, July 21, 2026.
This does not mean the warning letter creates a universal competency-testing requirement for every industry or every type of training. It is a current medical-device enforcement example demonstrating the distinction between documenting training and evaluating understanding.
FDA made the distinction even more directly in a May 20, 2026 warning letter to 3B Medical, Inc. dba Reach Health. The firm’s own Training and Competency Procedure required an evaluation of training effectiveness. FDA found that effectiveness checks had not been performed for certain employees after training on complaint-handling and electronic Medical Device Reporting procedures.
The company’s corrective response included a training-gap assessment, verification of training completeness, training-effectiveness checks, role-based training needs, defined effectiveness-verification methods, and management oversight.
Source: U.S. Food and Drug Administration. 3B Medical, Inc. dba Reach Health, Inc. — Warning Letter 725108, May 20, 2026.
Again, this is a medical-device enforcement example. The applicable requirements depend on the regulatory and quality framework that governs the work.
| Level | What it demonstrates |
|---|---|
| Training assigned | The organization identified a training need |
| Training completed | The employee participated in the required training |
| Understanding verified | The employee demonstrates comprehension of the material |
| Competency demonstrated | The employee can correctly perform the applicable task |
| Ongoing performance | Competency continues during actual work |
Not every training activity needs all five levels. An employee reading an updated vacation-policy statement does not need the same qualification process as someone performing sterile operations, conducting laboratory testing, calibrating equipment, inspecting product, making product-acceptance decisions, conducting internal audits, performing root-cause investigations, or reviewing regulated electronic records. The control should be proportional to risk.
Reading can absolutely be an appropriate training method. For a simple administrative change, read-and-understand training may be sufficient — for example, a requirement changing from “submit form to Quality” to “submit form through the electronic QMS.” A simple review may adequately communicate that change.
But consider a procedure describing a laboratory test, equipment setup, a calibration activity, sterile gowning, product inspection, or a complex investigation methodology. Reading may be only one part of the training process. The organization may also need demonstration, supervised practice, observation, a practical assessment, a knowledge check, qualification, and independent work only after approval. The method should fit the task.
Don’t start with: “Who needs to read this SOP?”
Start with: “What does this person need to be able to do after the training?”
That question changes training design. If the answer is “know that the document changed,” read-and-understand may be enough. If the answer is “correctly perform a new calibration procedure,” then simply acknowledging the document may be insufficient. Training should be designed backward from the expected performance.
| Type of change or activity | Possible verification |
|---|---|
| Minor administrative update | Read and acknowledge |
| Policy or QMS requirement | Read + short knowledge check where useful |
| New form or workflow | Demonstration or guided practice |
| Technical procedure | Observation / practical demonstration |
| Inspection or testing activity | Qualification against defined criteria |
| High-risk regulated operation | Formal qualification and periodic reassessment where appropriate |
These are examples, not universal regulatory requirements. The appropriate method depends on risk, complexity, applicable requirements, and the organization’s processes.
Competency should be connected to the task.
Can the employee correctly initiate, revise, route, and issue a controlled document?
Can the technician perform the calibration correctly, recognize an out-of-tolerance condition, and document the result?
Can the auditor gather evidence, interview personnel, identify meaningful findings, and document objective evidence?
Can the investigator distinguish the event from the cause and develop an evidence-based investigation?
Can the operator perform the process within established parameters and correctly respond to abnormal conditions?
The evidence does not have to be complicated. It needs to demonstrate something meaningful.
Depending on the work, organizations may use:
The goal is not to add an exam to every SOP. The goal is to use an appropriate method when simply documenting completion does not provide enough assurance.
When something goes wrong, organizations often respond: employee error → retrain employee. But before assigning retraining, ask whether there was actually a knowledge gap, whether the employee was already trained, whether the employee had previously demonstrated competency, whether the procedure was clear, whether the process was realistically executable, and whether the same problem has occurred with other trained employees.
If a competent, properly trained employee makes the same error that several other trained employees have made, additional training may not solve the problem. The issue may instead involve process design, workload, interface design, equipment, similar materials, poor instructions, or missing controls. This is the same reasoning behind investigating beyond “human error”.
A new revision number does not automatically tell you the training risk. Compare two revisions:
Those revisions should not necessarily trigger identical training. A mature training process considers what changed, who is affected, whether the change alters how work is performed, whether it alters a decision, whether it introduces a new risk, whether it requires new knowledge or skill, and whether competency needs to be demonstrated. This is where an electronic QMS can help.
A useful training system should help answer: What training does this role require? Has the employee completed it? Which document revision was involved? Was qualification required? Has competency been demonstrated? Is retraining required after this change? Is any qualification expiring? Is anyone performing work before becoming qualified?
That is significantly more useful than a spreadsheet with hundreds of dates and checkmarks.
For a selected employee and activity, the organization should be able to tell a coherent story. For example:
| Role | Calibration Technician |
| Required qualification | Calibration Procedure CAL-001 |
| Training | Completed May 5 |
| Practical qualification | Observed successfully performing required calibration steps May 7 |
| Authorized for independent work | May 8 |
| Procedure revised | July 12 |
| Change assessment | Revision changed documentation only; no requalification required |
The important thing is not having more records. It is having records that demonstrate the organization made a reasonable determination that the employee was capable of performing the assigned work.
The answer is not to test employees after every procedure revision, require annual requalification for every task, create long examinations for low-risk activities, add supervisor signoffs that provide no meaningful evidence, or generate paperwork solely for the audit. That defeats the purpose.
Use risk. A quality system should apply stronger competency controls where failure could create more significant consequences. Simple activities should remain simple. Complex or high-risk activities deserve greater assurance.
Before closing a training assignment, consider:
The goal is not more training records. The goal is confidence that qualified people can perform the work correctly.
A training record answers: “Did we provide the training?”
Competency answers: “Can the person perform the work?”
Both matter. For low-risk activities, training completion may provide sufficient evidence. For higher-risk or technically demanding work, organizations may need greater assurance that employees understood the requirements and can apply them correctly.
A mature QMS does not measure training success by the number of completed assignments. It measures whether people are prepared to perform the work the quality system depends on.
